US President Joe Biden has taken a bold stance on the intellectual property (IP) rights of pharma companies, siding with India, South Africa, and Pope Francis to endorse a temporary patent waiver on Covid vaccines. While Biden’s decision might be the most visible setback to hit Pfizer and Moderna since their mRNA vaccines became the hottest products on the planet, it also puts pressure on the UK and Europe to follow Washington’s lead
While the announcement marks a major step in moral terms, its impact on the global vaccination drive is likely to be more muted. As Moderna’s CEO points out, the obstacles to expanding global production of his company’s revolutionary product go well beyond IP. Insufficient manufacturing capacities, the difficulties of disseminating knowledge, and the logistical complexities related to storage and distribution mean waiving patents will not be enough to overcome the pandemic.
Instead, mRNA vaccines must be supplemented by second generation treatments capable of bypassing these challenges and ensuring everyone on the planet can access effective vaccines in a timely yet equitable manner.
IP not the only issue
Even if Biden’s announcement marks a stunning U-turn in US policy, critics have raised serious doubts over the actual value of the move. Bill Gates has expressed concerns that lifting patents could allow for substandard products to infiltrate the market, while France’s Emmanuel Macron and Germany’s Angela Merkel are both critical of Washington’s unwillingness to export some of the vast stores of vaccines it has already stockpiled.
Meanwhile, Moderna CEO Stéphane Bancel has indicated he doesn’t believe the patent waiver will affect sales of his company’s vaccines, since production capacity and quality standards are a far greater obstacle to widespread vaccine manufacturing than IP. Analysts from Morgan Stanley appear to agree with him, given the World Trade Organization (WTO) does not have the power to force major companies to share their expertise and that scaling up existing operations is likely to take the better part of a year. With thousands dying in India on a daily basis, more vaccines are needed now – not in 2022.
Then, of course, there’s the human element. The Oxford/AstraZeneca vaccine was intended to be the “workhorse” of global vaccination efforts, with its $2.50 per dose price-tag more accessible to developing nations than the $15-$25 attached to Pfizer and Moderna jabs. However, the AstraZeneca jab’s links with blood clotting has prompted a number of European countries to modify the terms of its rollout and damaged its reputation overseas. Given the AstraZeneca vaccine was originally expected to comprise up to 50% of vaccine supplies in low- and middle-income countries, hesitancy over its use is already proving disastrous.
2nd generation solutions
Even if production capacity and consumer trust were not an issue, there’s also the cold chain infrastructural deficit to consider. In one illuminating Wall Street Journal case study, doses of AstraZeneca produced at the Serum Institute of India in Pune had to travel 1,500 miles over 120 days and various forms of transport, including riverboats, to reach remote villages in the far north-eastern Indian state of Mizoram. A lack of basic infrastructure across wide stretches of sub-Saharan Africa means vaccine distribution there will be an equally arduous undertaking, representing a challenge for communities residing in rural and remote areas as well as the health services attempting to vaccinate them.
Fortunately, there are an array of second-generation vaccinations in the pipeline which promise to circumvent such difficulties. One prominent candidate from Akston Biosciences has just entered a Phase I/II human trial in the Netherlands, with 176 healthy volunteers receiving doses of the new vaccine. The science behind the treatment is simple enough that a single 2,000-litre production line could theoretically produce over one billion doses per year. Even more importantly, the ability of the Akston vaccine, AKS-452, to retain its potency at 25°C for four months (and 37°C for one month) could eliminate the logistical issues facing mRNA vaccines in one fell swoop. As the Dutch trial’s lead investigator, Dr. Schelto Kruijff, points out: “From my volunteer work in Malawi and Kenya, I understand how important it would be to have a vaccine like this, which can be transported and stored for months without refrigeration.”
A total of 277 new vaccines are in development, with 93 already at the testing stage. Seven of those involve nasal administration, while two are oral formulations. Both of those routes would be significantly easier than injection, persuading more people to put aside their vaccination hesitancy. According to a recent poll in the US, 23% of respondents said they would not consider a Covid-19 inoculation jab, but one third of that group would be amenable to an orally administered tablet. There’s also the pursuit of additional single-dose solutions, building off the example of simplicity set by the one-shot Johnson & Johnson vaccine.
Patent waiver more political than practical
It’s clear existing vaccine options are not sufficient to overcome the pandemic alone, and even if Biden’s push for waiving patents gains global traction, there is no telling how long the bureaucratic machinations surrounding the move will take to play themselves out. For example, it took years for the WTO to agree upon amendments to regulations surrounding HIV treatments, while the Pfizer vaccine has not yet even gained approval in India.
Instead, it’s clear the global vaccine economy is in desperate need of a new set of players before it can inoculate the planet and close the door on this traumatic chapter in human history. Biden’s backing of patent waivers may be impressive in political terms, setting an example for British and European authorities while turning up the heat on Big Pharma to prioritise public health over private profit, but the logistical hurdles associated with the new class of mRNA vaccines means it will take far more to truly curb the global spread of Covid-19 – especially within the timescale required.